ClearanceBrief
510(k) K201511 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed

Reprocessed Endoscopic Trocars and Sleeves

ApplicantStryker Sustainability Solutions, Tempe AZ, US
DecisionSubstantially Equivalent, Jul 31, 2020
ReceivedJun 5, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K201511

DateFirm and productCodeLinked 510(k)
Sep 16, 2026Stryker Sustainability Solutions
REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
Open, Classified
NLMNone listed
Sep 16, 2026Stryker Sustainability Solutions
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Open, Classified
NLMNone listed
Sep 16, 2026Stryker Sustainability Solutions
REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
Open, Classified
NLMNone listed
Sep 16, 2026Stryker Sustainability Solutions
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Open, Classified
NLMNone listed
Sep 16, 2026Stryker Sustainability Solutions
REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
Open, Classified
NLMNone listed
Sep 16, 2026Stryker Sustainability Solutions
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Open, Classified
NLMNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.